Z-1377-05

Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0

Name: Z-1377-05 Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0
Creator: Beckman Coulter Inc
Published: 2005-07-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-07-06 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0 on 2005-07-06. The reason FDA records is "Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1377-05
Status: Terminated
Initiated: 2005-07-06
Posted: 2005-08-17
Terminated: 2012-04-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0
Product code: GKZ Counter, Differential Cell
Reason for recall: Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.
Root cause tag: software
FDA root cause: Other
Action: Letters issued to users on July 13, 2005 which also included modified operating instructions, and response cards.
Quantity in commerce: 36
Distribution: USA
Product codes and lots: Versions 1.1 and 2.0

Product code GKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)